Table 3.

Integrated safety analysis from the SC abatacept and IV abatacept clinical trial programs.

	SC abatacept n = 1879 3086 patient-years		IV abatacept n = 4149 12,132 patient-years
	N	Events/100 patient-years (95% confidence interval)	N	Events/100 patient-years (95% confidence interval)
Deaths	17	0.55 (0.34–0.89)	73	0.60 (0.47–0.76)
Overall SAEs	274	9.53 (8.46–10.72)	1373	14.61 (13.85–15.41)
Infections	1013	53.91 (50.69–57.33)	2998	75.68 (73.00–78.44)
Serious infections*	59	1.94 (1.50–2.50)	332	2.87 (2.57–3.19)
Malignancies, excluding nonmelanoma skin cancer	21	0.68 (0.45–1.05)	88	0.73 (0.58–0.89)
Autoimmune events	39	1.28 (0.93–1.75)	232	1.99 (1.74–2.26)

^*Subset of infections.

AE, adverse event; IV, intravenous; SAE, serious adverse event; SC, subcutaneous.